MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR HANDPIECE MAX 16000 RPM

Model Number 89955.0003

Device Problem Intermittent Continuity (1121)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer reported: during the inspection of the motor handpiece max.16000rpm in the specialist department according to (b)(4), a short circuit (coil-ground, coil-housing) was detected.After production, the motor handpiece max.16000rpm type 89955.0003 will be subjected to final inspection according to (b)(4).These inspection steps ensure that no products are shipped that do not met their specifications.Since neither a processing/manufacturing defect nor customer fault can be identified, the cause of the short circuit cannot be clearly traced.The motor handpiece max.16000rpm type 89955.0003 with the serial number (b)(4) was produced on 23.04.2020 (with a batch size of 5 pieces) and delivered to the customer on 12.05.2020.A review of the production schedule did not reveal any deviations nor could any special releases be identified.There is no direct patient risk, since in the event of a defect there is no loss of parts and no irreversible damage.In general, the user is advised in the associated ga-a238 instructions for use under chapter four (4) that a visual and functional check must be performed before and after each use.Possible damage/malfunctions of the above type can be easily detected by the hospital staff if these instructions are followed.In our risk analysis e5-2, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.In the period under consideration, no comparable case of this type 89955.0003 with "coil - short circuit" has been registered.As no new risks have arisen from the investigation of the current complaint case, the risk assessment described facts continues to be valid.No manufacturing defect.Based on the results described above the cause of the fault, short-circuit, at the coil is not comprehensible.Measures are not necessary due to the test results and because this is an individual case of this type richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.

Event Description

It was reported to rw gmbh by the user facility that "accessories motor shaver break off, surgery delay of five (5) hours and surgery was close to the nerve".

• Brand Name: MOTOR HANDPIECE MAX 16000 RPM
• Type of Device: MOTOR HANDPIECE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11856460
• MDR Text Key: 251978865
• Report Number: 9611102-2021-00019
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K080617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89955.0003
• Device Catalogue Number: 89955.0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1